The Genetically Modified Organisms (Amendment) (EU Exit) Regulations 2019 No. 90

PART 4 U.K. Amendments to retained direct EU legislation

CHAPTER 1 U.K. EU Regulations

Commission Regulation (EC) No 65/2004 U.K.

6.—(1) Commission Regulation (EC) No 65/2004 establishing a system for the development and assignment of unique identifiers for genetically modified organisms is amended as follows.

(2) For Article 1 substitute—

“Article 1 U.K.

1.   This Regulation applies to genetically modified organisms, hereinafter ‘GMOs’, authorised for placing on the market in accordance with Regulation 1829/2003 of the European Parliament and of the Council [F1 or ] —

(a) in England, the Genetically Modified Organisms (Deliberate Release) Regulations 2002,

(b) in Wales, the Genetically Modified Organisms (Deliberate Release) (Wales) Regulations 2002,

(c) in Scotland, the Genetically Modified Organisms (Deliberate Release) (Scotland) Regulations 2002,

F2 (d) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

and applications for placing on the market under such legislation.

[F3 2.   This Regulation does not apply to medicinal products for human and veterinary use authorised under—

(a) Regulation (EC) No 726/2004 of the European Parliament and of the Council,

(b) the Human Medicines Regulations 2012, or

(c) the Veterinary Medicines Regulations 2013,

or applications for authorisation under such legislation.”].

(3) In Article 2(2), after “Biosafety clearing house” insert “ established by the Cartagena Protocol on Biosafety to the Convention on Biological Diversity (the “Biosafety clearing house”) ”.

(4) In Article 3—

(a) in point (b), for the words from “Commission” to “original application” substitute “ Secretary of State ”;

(b) for point (c) substitute—

“(c) for GMOs authorised under Regulation (EC) No 1829/2003, the unique identifier must be recorded in the register maintained in accordance with Article 28 of that Regulation.”.

(5) Omit Articles 4 to 6.

(6) After Article 7, omit the words from “This Regulation” to “Member States.”.

(7) In the Annex—

(a) in Section A, in paragraph 1, in the first subparagraph, omit “under Community legislation”;

(b) in section B, for “endorsed at Community level” substitute “ implemented in [F4 Great Britain] ”.

Textual Amendments

F1 Word in reg. 6(2) substituted (31.12.2020 immediately before IP completion day) by The Food and Farming (Amendment) (EU Exit) Regulations 2019 (S.I. 2019/759), regs. 1(a), 12(3); 2020 c. 1, Sch. 5 para. 1(1)

F2 Words in reg. 6(2) omitted (31.12.2020 immediately before IP completion day) by virtue of The Genetically Modified Organisms (Amendment) (EU Exit) Regulations 2020 (S.I. 2020/1421), reg. 1(4), Sch. para. 4(2)(a)

F3 Words in reg. 6(2) substituted (31.12.2020 immediately before IP completion day) by The Genetically Modified Organisms (Amendment) (EU Exit) Regulations 2020 (S.I. 2020/1421), reg. 1(4), Sch. para. 4(2)(b)

F4 Words in reg. 6(7)(b) substituted (31.12.2020 immediately before IP completion day) by The Genetically Modified Organisms (Amendment) (EU Exit) Regulations 2020 (S.I. 2020/1421), reg. 1(4), Sch. para. 4(3)

Commencement Information

I1 Reg. 6 in force at 31.12.2020 on IP completion day (in accordance with 2020 c. 1, Sch. 5 para. 1(1)), see reg. 1(2)(b)